{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA071500"
        ],
        "brand_name": [
          "FLUOCINONIDE"
        ],
        "generic_name": [
          "FLUOCINONIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-1386"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FLUOCINONIDE"
        ],
        "rxcui": [
          "103456"
        ],
        "spl_id": [
          "3972605f-b081-0289-e063-6294a90ab0e3"
        ],
        "spl_set_id": [
          "5782d791-48fd-4cee-853d-235eb4d04a40"
        ],
        "package_ndc": [
          "51672-1386-1",
          "51672-1386-2",
          "51672-1386-3",
          "51672-1386-4"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "2W4A77YPAN"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98677",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0475-2026",
      "product_description": "Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1",
      "product_quantity": "24,672 15 g tubes",
      "reason_for_recall": "Failed Viscosity Specifications:  Out of Specification results, above the specification limit, in viscosity, noted during stability testing.",
      "recall_initiation_date": "20260325",
      "center_classification_date": "20260413",
      "report_date": "20260422",
      "code_info": "Lot# AD76252, Exp Date: 6/30/2026."
    }
  ]
}